Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs— 510(k) K161154

Name: FDA 510(k) clearance K161154
Creator: U.S. Food and Drug Administration
Published: 2016-07-23

Substantially Equivalent

Spr Therapeutics, LLC

FDA 510(k) clearance K161154 for Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs, Substantially Equivalent on 2016-07-23. Applicant: Spr Therapeutics, LLC. Device class: 2.

Clearance details

Applicant: Spr Therapeutics, LLC
Product code: Code NHI
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2016-04-25
Decision date: 2016-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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